Kornimate/medical-research-clean huggingface dataset:
study on the preventive effect of establishing an integrated working group of doctors and nurses in operating room

Conditions: Orthopedic Disorder; Incision Infection

Summary: to explore the preventive effect and clinical enlightenment of establishing an integrated working group of doctors and nurses in operating room on incision infection in orthopedic surgery.

surgery is the most used treatment in orthopedics. during orthopedic surgery, the integrity of the skin barrier is compromised, resulting in direct exposure of sterile tissue to the external environment and the potential impact of surgical instruments on local tissue. additionally, orthopedic surgery procedures often entail prolonged duration, extensive surgical areas, and significant blood loss, all of which contribute to an elevated risk of surgical site infections. however, there are some limitations in the practical application of the conventional nursing model in the operating room. against this backdrop, numerous new nursing models have emerged to meet contemporary demands. among them, the integration of medical and nursing staff (mans) in the operating room has garnered significant attention. presently, this integrated model is predominantly employed in critical care settings and for postoperative infection prevention. however, the establishment and effectiveness of an integrated working group comprising both mans in the operating room remains in its nascent stage of exploration, warranting further investigation into its clinical impact and implications.

Eligibility criteria:
inclusion criteria: * (1) all selected cases met the relevant diagnostic criteria outlined in the orthopedic disease guidelines. diagnosis was confirmed through imaging methods. (2) the patients ranged in age from 18 to 70. (3) all individuals underwent surgery in the orthopedic department of our hospital. (4) the vital signs of the patients were essentially stable. (5) patients possessed normal cognitive function before the operation and demonstrated the ability to listen, speak, read, and write. exclusion criteria: * (1) orthopedic patients with multiple injuries in other locations (such as craniocerebral trauma, chest trauma, etc.); (2) patients with severe internal diseases, such as severe anemia, severe diabetes, liver insufficiency; (3) patients with chronic infectious diseases; (4) patients with malignant tumor; (5) patients with pathological fracture, such as bone tumor; (6) patients with mental diseases and cognitive impairment.

Keywords: orthopedic disorder incision infection operating room integration of medical staff
different doses of zed1227 vs. placebo in nafld

Conditions: NAFLD; Liver Fibrosis

Summary: this is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase ii dose-finding trial. the trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg zed1227 vs. placebo for the treatment of patients with nafld with fibrosis.


Eligibility criteria:
inclusion criteria: * has provided signed informed consent * is a male or female ≥ 18 and \< 75 years of age * has diagnosed nafld * has diagnosed significant fibrosis (stages 2 or 3) exclusion criteria: * has a history of significant alcohol consumption (an average of \> 20 g/d in females and \> 30 g/d in males) * has a history or presence of any other significant concomitant liver diseases * has diagnosed type 1 diabetes mellitus (t1dm) * has presence of cirrhosis
experimental medicine in adhd - cannabinoids

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: adult patients with adhd commonly report an improvement in behavioural symptoms when using cannabis with some reporting a preference towards cannabis over their adhd stimulant medication. the ema-c study aims to investigate the effects of a cannabis based medication, sativex oromucosal spray on behaviour and cognition in adults with adhd. this will be carried out by conducting a placebo controlled trial. 30 adults with adhd will take sativex or a dummy medication (a placebo) every day for 6 weeks. there is a 50% chance of receiving the sativex or placebo. measures of behaviour and cognition will be taken before and after 6 weeks of treatment. we hypothesise that treatment with sativex will result in improvements in behaviour and cognition above that of the placebo group.


Eligibility criteria:
inclusion criteria: * the study is open for both men and women aged 18-55 who meet dsm 5 criteria for adhd (n= 30). subjects will be either unmedicated or medicated with stimulant medication only and be willing to come of this medication for 1 week before and for the duration of the study. to ensure that this does not disadvantage patients we will only include those on stimulant medication who do not take medication on a regular basis and where short periods of medication are not thought by both the patient and psychiatrist to represent a clinical problem in the overall control of the symptoms and impairments. for example, by including patients who are considering a "stimulant drug holiday", which is a common clinical procedure in adhd. subjects must not use other prescription and non-prescription medication or recreational drugs during the study. exclusion criteria: * exclusion criteria will include autism spectrum disorders and other psychiatric disorders including recurrent major depression, bipolar i disorder, any psychotic disorder and obsessive compulsive disorder and learning difficulties defined as an iq \< 70. neurological problems and known or suspected history of a drug or alcohol dependence disorder. subjects who are using or have used cannabis or cannabis based medications in the 30 day period prior to study entry. concurrent history of renal, hepatic, cardiovascular or convulsive disorders. females who are pregnant or breastfeeding. female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use two effective forms of contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (note: a male condom should not be used in conjunction with a female condom).

Keywords: adhd, cannabis, sativex, endocannabinoid, cognition
flow-flow ecco2-r and 4 ml/kg tidal volume vs. 6 ml/kg tidal volume to enhance protection from vili in acute lung injury

Conditions: Acute Respiratory Distress Syndrome

Summary: the main objective of this randomized multicenter clinical trial is to test the hypothesis that further reduction of vt to 4ml/kg may enhance lung protection in patients with ards as compared to the conventional "ards-net" ventilation. control of paco2 in the \~4 ml/kg arm would be accomplished by lfppv- ecco2-r.

the trial will test the hypothesis that a vt of 4 ml/kg pbw combined with low flow co2 removal improves outcome in patients with severe ards (pfs ≤ 200 and peep ≥ 10) compared to ventilation with a vt of 6 ml/kg pbw. the study will accrue a maximum of 230 patients over approximately 12-18 months. primary end-point: number of ventilator-free days (vfds) during the 28 days immediately after randomization secondary end-points: 28 and 90-day all-cause mortality; number of icu-free days during the 28 days immediately after randomization; cumulative incidence of: first episode of refractory hypoxemia (during 28 days after randomization), use of rescue therapies, first day that meet criteria for weaning, sofa-free and severe adverse events. patients in control will be treated according to a modified, simplified version of the ards-network lung protective lower tidal volume. patients in treatment group will be treated according to the ards-net protocol modified (vt reduced by 1 ml/kg pbw at intervals ≤ 2 hours until vt = 4ml/kg pbw and the use of low-flow co2 removal with a plateau pressure goal: ≤ 25 cm h2o).

Eligibility criteria:
inclusion criteria: * age \> 18 years * are on invasive assisted breathing less then 48 hours * less than 24 hours since diagnosis for ards: with pf\ =10, bilateral infiltrate on chest x-ray and no clinical evidence of left atrial hypertension * have a commitment to full support exclusion criteria: * intubation and mechanical ventilation (any form) for \> 48 hours * risk of systemic bleeding with anticoagulation * acute brain injury * body mass index \> 40 * neuromuscular disease that impairs ability to ventilate without assistance * severe chronic respiratory disease * burns \> 40% total body surface area * malignancy or other irreversible disease or condition for which 6- month mortality is estimated to be greater than 50% * allogeneic bone marrow transplant within the last 5 years * chronic respiratory condition making patient respirator dependent * patient, surrogate, or physician not committed to full support * acute myocardial infarction or acute coronary syndrome within 30 days * moribund patient: not expected to survive 24 hours * no consent/inability to obtain consent * patients receiving high frequency ventilation

Keywords: ards: acute respiratory distress syndrome low flow ecco2-r: extra-corporeal co2 removal vili: ventilator induced lung injury
lod before ivf/icsi in pcos patients with high amh

Conditions: Infertility; Polycystic Ovarian Syndrome

Summary: to evaluate the effect of performing laparoscopic ovarian drilling (lod) before proceeding to in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) on the cycle outcomes in polycystic ovarian syndrome (pcos) patients with high antimullerian hormone (amh) levels

retrospective case-control study of pcos women with high serum amh level (≥ 7 ng/ml) who were subjected ivf/icsi. women underwent lod in the preceding 3 months prior to ivf/icsi (study group) will be compared with a control group of women who did not underwent lod (control group)

Eligibility criteria:
inclusion criteria: * pcos women subjected to cos through fixed gonadotropin releasing hormone (gnrh) antagonist protocol with final triggering of oocyte maturation by gnrh agonist (gnrha) * elevated serum amh level (≥ 7 ng/ml) exclusion criteria: * age \ 35 years * body mass index (bmi) \ 35 kg/m2 * use of cabergoline therapy or coasting to minimize the risk of ohss

Keywords: lod pcos amh ohss
effects of a food supplement on quality of life in patients with chronic obstructive pulmonary disease.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: it has been demonstrated that consequences of malnutrition affect a situation of risk and have negative effects on the evolution of chronic obstructive pulmonary disease (copd), accompanied by higher morbidity and mortality. the impact of malnutrition on the respiratory system affects the respiratory muscles, the lung parenchyma, and the immune system. in summary, the risk of complications can lead to a worsening of the quality of life of the copd patient. also, dyspnea as the main symptom of copd is the one that produces the greatest loss of quality of life, especially in older patients. the components of our authorized food supplement improve the quality of life of the patient. these components maintain the strength and energy of the patient, help the body to recover and regain its optimal state, help improve the immune system, help reduce the side effects of therapies associated with the control or cure of cancer and help correct nutritional deficiencies. this is the reason why this experimental study aims to improve the quality of life in patients with copd with a cat score\>15.

this study is developed in two phases: pilot phase and experimental phase. the pilot phase is preliminary and progressive in order to demonstrate a sufficient effect of improving the quality of life of patients and to be able to continue in an experimental phase with more investigational sites and more patients, and to evaluate other secondary objectives. once the pilot phase is finished, an intermediate analysis of the results will be carried out to evaluate the magnitude of the variation in quality of life at 3, 6, 9 and 12 months. if the expected success expectations are achieved and it is approved by the ethics committee, the study will continue to the experimental phase.

Eligibility criteria:
inclusion criteria: * adults: men and women ≥ 18 years. * patients with a medical diagnosis of copd based on a recent spirometry. * patients with a cat score\> 15, affecting copd symptoms in a moderate-high way in the daily life of these patients. * minimum clinical stability period of 4 weeks before the start of the study. * patients who are trained to give informed consent. * patients must agree to perform study visits and procedures with precise instructions. exclusion criteria: * bmi ≥ 40. * comorbidities, which due to their severity or progression, may interfere with the results, such as cancer, hematological disorders, severe heart or liver failure, kidney failure on dialysis, tuberculosis (tb) or aids, or other pulmonary pathologies such as pulmonary thromboembolism ( pe), pulmonary fibrosis, or relevant bronchiectasis. * in pulmonary rehabilitation treatment or in treatment for smoking. * pregnancy or breastfeeding. * impossibility of the patient, due to a medical condition, to follow the study.
the potential role for adenosine in the haemodynamic effects of free fatty acids

Conditions: Obesity; Metabolic Syndrome X

Summary: the metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. recently, bakker et al. (atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. the investigators hypothesize that in patients with obesity and the metabolic syndrome, an increased intracellular concentration of long-chain fatty acyl (lcfa)-coa (the intracellular equivalent of free fatty acids) induces an increase in adenosine. adenosine receptor stimulation, in turn, induces vasodilation and sympathetic activation. the investigators aimed to assess this effect of free fatty acids on the adenosine system in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * pregnancy * asthma * use of medication * cardiovascular/pulmonary disease and diabetes

Keywords: free fatty acids vasodilation sympathetic activity
troriluzole in adult participants with spinocerebellar ataxia

Conditions: Spinocerebellar Ataxias; Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 3; Spinocerebellar Ataxia Type 6; Spinocerebellar Ataxia Type 7; Spinocerebellar Ataxia Type 8; Spinocerebellar Ataxia Type 10

Summary: the purpose of this study is to compare the efficacy of troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (sca).


Eligibility criteria:
inclusion criteria: 1. participants with a known or suspected diagnosis of the following specific hereditary ataxias: sca1, sca2, sca3, sca6, sca7, sca8 and sca10. 1. a participant should have a confirmed genotypic diagnosis from a clinical laboratory improvement amendments (clia) certified lab (can produce test results); or, 2. a participant has a family member that has a confirmed genotypic diagnosis from a clia certified lab (can produce test results) and must be willing to undergo genetic testing to confirm underlying sca diagnosis; or, 3. a participant has a confirmed genotypic diagnosis from a lab that is not clia certified and must be willing to undergo genetic testing to confirm underlying sca diagnosis; or, 4. a participant has clinical evidence that supports diagnosis of one of the aforementioned sca genotypes but does not have producible test results from a clia certified lab from either a family member or for his or herself and the participant must be willing to undergo such testing to confirm the sca diagnosis (in this case, site must wait for results of genotypic testing prior to randomization) 2. ability to ambulate 8 meters without human assistance (canes and other devices allowed) 3. screening modified functional scale for the assessment and rating of ataxia (f-sara) total score ≥3. 4. score of ≥1 on gait subsection of the f-sara 5. determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. exclusion criteria: 1. a ≥ 2-point difference on the modified functional sara score between screening and baseline 2. mini mental state exam (mmse) score \<24 3. any medical condition other than one of the hereditary ataxias specified in the inclusion criteria that could predominantly explain or contribute significantly to the participants' symptoms of ataxia. 4. a prominent spasticity or dystonia that, in the opinion of the investigator, will compromise the ability of the sara instrument to assess underlying ataxia severity. 5. a score of 4 on any individual item (items 1-4) of the f-sara 6. participants should be excluded at screening or baseline if medical conditions have arisen or there is a change in disease status that could confound the ability of the sara to accurately reflect changes in ataxia severity. 7. active liver disease or a history of hepatic intolerance to medications that in the investigator's judgment, is medically significant.

Keywords: ataxia, sca, spinocerebellar ataxia
a feasibility study to collect data in patients with haemophilia

Conditions: Hemophilia

Summary: the purpose of this study is to collect reference data in patients with haemophilia. the study will also collect and store blood samples for potential future exploratory research in the disease area.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * patients with haemophilia, all severities * at least 18 years old. exclusion criteria: * no exclusion criteria

Keywords: haemophilia patients with haemophilia
feasibility study of bmac enhanced cabg

Conditions: Congestive Heart Failure

Summary: patients undergoing cabg will have 60 ml of bone marrow drawn, concentrated in a smartprep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

patients undergoing cabg will have 60 ml of bone marrow drawn, concentrated in a smartprep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. control subjects will undergo cabg only

Eligibility criteria:
inclusion criteria: * age\> 18 years and ability to understand the planned treatment. * patients with ischemic congestive heart failure requiring by pass surgery * congestive heart failure with ejection fraction ≤ 40%. * serum bilirubin, sgot and sgpt ≤2.5 time the upper level of normal. * serum creatinine \< 3.0 or no dialysis. * nyha performance status ≥ 3. * negative pregnancy test (in women with childbearing potential). * subject has read and signed the irb approved informed consent form * hematocrit ≥ 28.0%, white blood cell count ≤ 14,000, platelet count ≥ 50,000, creatinine ≤ 3.0 mg / dl, and/or no dialysis, inr ≤ 1.6 unless on coumadin, or ptt \<1.5 x control (to avoid bleeding complications) patients on coumadin will be corrected prior to the procedure and must have an inr\<1.6 at the time of randomization/surgery exclusion criteria: * female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study. * history of prior radiation exposure for oncological treatment. * history of bone marrow disorder (especially nhl, mds) that prohibit transplantation. * history of abnormal bleeding or clotting. * history of liver cirrhosis. * acute myocardial infarction \< 4 weeks from treatment date. * known active malignancy or results outside of normal limits from the following tests: pap, chest x-ray, psa, mammogram, hemoccult unless follow-up studies reveal patient to be cancer free. * active clinical infection being treated by antibiotics within one week of enrollment * terminal renal failure with existing dependence on dialysis * inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent. * unable to have 250cc bone marrow harvested. * medical risk that precludes anesthesia or asa class 5 * history of ventricular arrhythmia if aicd is not present. * history of ventricular aneurysm. * concurrent surgery such as cabg with valve surgery. * minimally invasive bypass surgery * life expectancy \<6 months due to concomitant illnesses * treatment with immunosuppressant drugs (including prednisone \> 5 mg per day) * patients undergoing urgent by pass surgical procedure * patients with hgb a1c \> 8.5%
protective ventilation based on alveolar ventilation in children

Conditions: Anesthesia; Peroperative Complication

Summary: protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. in children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. therefore, it is difficult to propose an "optimal" tidal volume for all children. the objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. the hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.


Eligibility criteria:
inclusion criteria: * children aged \< 12 and * weight between 5 and 40kg * general anesthesia * non-opposition of parents or legal guardians exclusion criteria: * history of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease * airleaks \> 10% * bronchospasm during anesthesia
generalized anxiety disorder adjunct study

Conditions: Anxiety; Anxiety Disorders; Anxiety Neuroses; Anxiety States

Summary: this study is being carried out to see if extended release quetiapine fumarate (seroquel®xl) when added to standard selective serotonin reuptake inhibitor (ssri) / serotonin-norepinephrine reuptake inhibitor (snri) therapy is effective and safe for the treatment of generalized anxiety disorder in patients with partial or no response to ssri/snri alone or in combination with a benzodiazepine, and if so, how it compares with placebo


Eligibility criteria:
inclusion criteria: provision of informed consent * documented diagnosis of generalized anxiety disorder * female patients must not be pregnant and be willing to use a reliable method of birth control * be able to understand and comply with study requirements exclusion criteria: other psychiatric disorders that could confound the study results, as judged by the study doctor * moderate to severe depression * other clinically relevant diseases, as judged by the study doctor * medication that you are taking, as judged by the study doctor

Keywords: generalized anxiety disorders anxiety adjunct treatment in anxiety anxiety disorder partial or non-responder in anxiety